原始来源记录
重大其他
LX2006：FDA 接受将 I/II 期汇总数据与关键性试验数据合并用于 BLA
FDA 表示愿意接受汇总 I/II 期数据与关键性试验数据用于加速批准 BLA，并同意在 12 个月前评估共同主要终点 LVMI。FDA 还批准了 HEK 转 Sf9 生产可比性报告，允许在注册研究中使用最终商业 Sf9 工艺。Lexeo 现计划于 2026 年上半年启动关键性试验。
关键事实
来源摘录
EX-99.1 2 lxeo-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Lexeo Therapeutics Reports Third Quarter 2025 Financial Results and Operational Highlights FDA open to pooling data from ongoing Phase I/II studies of LX2006 with data from pivotal trial, and to earlier co-primary endpoint assessment, to support a Biologics License Application FDA approved comparability report between LX2006 HEK and Sf9 manufacturing processes in November 2025, endorsing use of Sf9 final commercial manufacturing process to begin dosing patients in upcoming pivotal study LX2006 interim clinical data show clinically meaningful improvements across cardiac and neurologic measures of Friedreich ataxia, including left ventricular mass index and the modified Friedreich Ataxia Rating Scale Completed enrollment of LX2020